Support for the preservation of biological samples and correlated method of production

ABSTRACT

A support for conserving a sample of biological material comprising at least a substantially rigid body made of moulded plastic material, comprising at least a first through opening and at least a first portion of an absorbent matrix suitable for conserving a sample of biological material, fixed within the first through opening. The first portion of the absorbent matrix has at least a first part without support from the body and suspended inside the first through opening, the first part being directly accessible to contact.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a U.S. National Phase Application under 35 U.S.C. §371 and claims the benefit of priority to International ApplicationSerial No. PCT/IB2018/059440, filed Nov. 29, 2018, which claims priorityto Italian Application Serial No. 102017000139132, filed Dec. 1, 2017,the contents of which are hereby incorporated by reference.

TECHNICAL FIELD

The concepts herein relate to a support for conserving samples ofbiological material, in particular a support comprising an absorbentmatrix suitable for receiving and conserving the sample. The conceptsherein further relate to the associated method for producing thesupport. The concepts herein have particular application for enabling,by a single support, the conservation of a sample of biological materialand cleaning of a device suitable for taking a sample of biologicalmaterial from the matrix support.

BACKGROUND

There are known supports for conserving samples of biological materialcomprising a matrix, usually made of absorbent material. The absorbentmatrix can consist of a cellulose-based material, such as, for example,paper, particularly absorbent paper or filter paper, which can bespecifically treated, in particular chemically, to enable the absorptionand conservation of the collected samples of biological material.

Such types of paper are known, for example, from patent applicationWO9003959 (BURGOYNE). Transferring samples of biological material thathave been collected by specific devices (e.g. swabs of varying nature,in particular, for example, flocked swabs) onto matrix supports of thetype previously described is known. Following the transfer of thesamples onto matrix supports, a portion of the sample can be taken fromthe matrix support, for example in order to be subsequently analysed.The step of taking a sample from the support can be carried out by aknown sample-taking device, such as a punch or a manual or automaticpunching machine suitable for separating a small portion of the matrixsupport from the support. A punching machine suitable for taking asample of biological material from a matrix support made of paper isknown, for example, from patent application WO2006056658 (LEHTINEN).

Sample-taking devices usually have one or more surfaces which, onentering into contact with the support for conserving biologicalmaterial, are designed to remove a portion of a sample of biologicalmaterial from the support. In particular, when the sample-taking deviceconsists of a punch, the portion removed from the matrix can bedisc-shaped. Following removal of a sample of biological material fromthe matrix support it is convenient and advisable to clean the surfacesresponsible for taking it, in order to be able then to proceed to take afurther sample of biological material by the same sample-taking device.Cleaning has the purpose of avoiding contamination, by the sample-takingdevice, of the subsequent support from which it is intended to take afurther sample of biological material. Such contamination could occur,for example, due to the presence of biological residues and/orimpurities on the surfaces of the sample-taking device designed to takethe sample of biological material from the support. Cleaning asample-taking device using a special cleaning support, distinct from theconservation support, is known. For example, if the device for taking asample of biological material from a first support is a punch, inaccordance with the known cleaning method, cleaning is performed bypunching once, in a “blank” mode, a “virgin” cleaning support devoid ofcontaminants, in particular an absorbent matrix, so that the contactbetween the head of the punch and the second support allows the removalof biological residues and/or impurities present on the punch itself. Inthe context of the present description, “virgin” support refers to amatrix support, or a portion thereof, on which no sample of biologicalmaterial has been deposited, whereas punching in a “blank” mode refersto the operation consisting in punching a virgin support in order toclean the punch. The known method is complex, as it requiresmanipulating both the conservation supports and the cleaning supports,which results in various drawbacks, including at least an increase incosts and a lengthening of processing times.

From document MI2013A001354, moreover, there is known a support forconserving samples of biological material comprising at least: a firstportion of an absorbent matrix suitable and intended for conserving asample of biological material and a second portion, distinct from thefirst portion and suitable for, configured and intended to constitute acleaning zone for the head of a device, in particular a punch, suitablefor taking a sample of biological material from the first portion. Thesupport can further comprise a third portion interposed between thefirst portion and the second portion; the third portion can have one ormore notches or one or more openings.

The paper supports of a known type described above show some drawbacks.

In particular, such paper supports are bendable and do not have anyappreciable rigidity; in manipulation with automatic loaders, automaticmanipulators and/or punching machines, bending of the supports may thusoccur, which may thus lead to malfunctions. It should be furtherconsidered that in automatic loaders, the spaces are limited, and hencethere is a need for great precision in positioning and manipulation bythe completely automated systems.

SUMMARY

The present disclosure encompasses a support for conserving one or moresamples of biological material which enables one or more of theabove-described drawbacks to be overcome.

Further aspects combinable with one or more of the appended claimsand/or with one another will be described below.

In accordance with a first aspect, there is provided a support forconserving a sample of biological material, the support comprising atleast:

-   -   a substantially rigid body made of moulded or co-moulded or        overmoulded plastic material, comprising at least a first        through opening;    -   at least a first portion of an absorbent matrix made of a        material comprising cellulose, suitable and intended for        conserving a sample of biological material; the first portion of        absorbent material being fixed and maintained in a predetermined        position within the first through opening;    -   wherein the first portion has at least a first part without        support from the body and which is suspended inside the first        through opening, the first part being directly accessible to        contact.

The use of a substantially rigid material to produce the body of thesupport enable greater precision in positioning the support insideautomatic loaders and reduces the risk of errors or malfunctions in themanipulation and punching of the first portion.

In accordance with a second non-limiting aspect, the first portion ofthe absorbent matrix is made of a material comprising cellulose.

In accordance with a third non-limiting aspect, the absorbent matrix,made of a material comprising cellulose, is in particular absorbentpaper or filter paper. Optionally, the absorbent paper or filter paperis specifically treated, in particular chemically, to enable theabsorption and conservation of the collected samples of biologicalmaterial.

In accordance with a fourth non-limiting aspect dependent on theaforesaid third aspect, the chemical treatment is a preserving chemicaltreatment, in particular DNA-compatible.

The use of a preserving chemical treatment, in particular aDNA-compatible one, advantageously enables biological samples conservedfor a long time to be maintained on the first portion of the absorbentmatrix.

In accordance with a fifth non-limiting aspect, the absorbent matrix isa matrix insoluble in liquid.

In accordance with a sixth non-limiting aspect, the absorbent matrix isa dimensionally stable matrix.

The use of a dimensionally stable matrix makes it possible to prevent orin any case reduce the risk of accidental contact at least of the firstportion with potentially contaminating surfaces, especially in the caseof superposition or juxtaposition of a number of supports. Suchpotentially contaminating surfaces are the surface of the body of othersupports, and/or other first portions of other supports, or walls ofstorerooms, or components of automatic manipulation and punchingsystems.

In accordance with a seventh non-limiting aspect, the support furthercomprises at least a second portion, separate from the first portion andsuitable for, configured and intended to constitute a cleaning zone forthe head of a device, in particular a punch, suitable for taking asample of biological material from the first portion; the second portionof absorbent material being maintained in a predetermined positionwithin a second through opening.

In accordance with an eighth non-limiting aspect, the first portioncomprises a second lateral part in contact and/or in adhesion, and inparticular surrounded by the body.

In accordance with a ninth non-limiting aspect, the first portion of theabsorbent matrix is maintained in a predetermined position within thefirst through opening at least by contact and/or adhesion between thesecond lateral part and the body.

In accordance with a tenth non-limiting aspect, the second portion is asecond portion of an absorbent matrix maintained in a predeterminedposition within a second through opening at least by contact and/oradhesion between a second lateral part and the body.

In accordance with an eleventh non-limiting aspect, the second portionis separated from the first portion by a part of the body.

In accordance with a twelfth non-limiting aspect, the absorbent matrixof the second portion is physically separated from the absorbent matrixof the first portion. In a variant, the two portions of the absorbentmatrix could consist of a single portion.

In accordance with a thirteenth non-limiting aspect, at least the firstportion of the absorbent matrix has a thickness that is smaller than orequal to a thickness of the body.

The difference in thickness between the first portion of the absorbentmatrix and the body contributes to increasing the certainty of isolatingthe first portion from accidental contacts, which could contaminate thebiological sample in use contained therein.

In accordance with a fourteenth non-limiting aspect, the thickness ofthe body is equal to or greater than 0.8 mm or 1.0 mm, more preferablycomprised in the interval of 1.2 mm-1.4 mm, optionally substantiallyequal to 1.3 mm, and/or equal to or less than 3.0 mm, more preferably2.0 mm and/or the thickness of the first portion of the absorbent matrixis equal to or greater than 0.2 mm or 0.4 mm, more preferably 0.5 mm or0.6 mm and/or equal to or less than 1 mm, more preferably 0.8 mm.

In accordance with a fifteenth non-limiting aspect, the body identifiesat least a first profile of discontinuity of thickness in a zone ofproximity to the first portion of the absorbent matrix.

In accordance with a sixteenth non-limiting aspect, the body identifiesat least a first profile of discontinuity of thickness in a zone ofproximity to the second portion.

In accordance with a seventeenth non-limiting aspect, alternative to thepreceding eleventh non-limiting aspect, the body identifies at least afirst profile of discontinuity of thickness and a second profile ofdiscontinuity of thickness in a zone of proximity to the first portionof the absorbent matrix.

In accordance with a preferred, non-limiting eighteenth aspect, thefirst profile of discontinuity of thickness is at the first surface ofthe first portion.

In accordance with a nineteenth preferred, non-limiting aspect, thesecond profile of discontinuity of thickness is at the second surface ofthe first portion.

In accordance with a twentieth preferred, non-limiting aspect, part ofthe body overlaps part of the first face or surface and of the secondface of the first portion of the absorbent matrix and the portions ofthe body overlapping the first portion of the absorbent matrix create astop impeding the axial mobility of the first portion of the absorbentmatrix relative to the body.

The creation of a stop impeding the axial mobility of the first portionrelative to the body makes it possible to have a great safety ofpositioning, and helps to maintain the first portion in its throughopening even following punching.

In accordance with a twenty-first preferred, non-limiting aspect, thebody is a substantially planar body extending mainly along a first and asecond direction respectively identified by a first reference axis (X)and a second reference axis (Y) identifying an upper face and a lowerface opposite the upper face, wherein the first and second throughopenings have an axis that extends substantially along a directionidentified by a third reference axis (Z) orthogonal to the firstreference axis (X).

In accordance with a twenty-second preferred, non-limiting aspect, saidfirst face and said second face are substantially parallel to the upperface and/or to the lower face.

In accordance with a twenty-third preferred, non-limiting aspect, thebody comprises a first portion and a second portion overlapping eachother in the direction identified by the third reference axis (Z) andenclosing the second lateral part of the first portion of the absorbentmatrix constrained to the body.

In accordance with a twenty-fourth preferred, non-limiting aspect, thebody comprises a first portion and a second portion overlapping eachother and made of a plastic material, in particular by moulding orco-moulding or overmoulding.

In accordance with a twenty-fifth preferred, non-limiting aspect, thebody comprises a first portion and a second portion overlapping eachother and made of a plastic material, joined to each other seamlesslyand/or indissolubly and/or so as to form a monolithic and/or integralpiece, in particular as a result of a moulding or co-moulding orovermoulding process. In accordance with a twenty-sixth preferred,non-limiting aspect, the impediment to axial mobility is an impedimentalong the third reference axis (Z).

In accordance with a twenty-seventh preferred, non-limiting aspect, thesupport comprises a radio-frequency identification chip comprising atleast one memory suitable for containing electronic data.

In accordance with a twenty-eighth preferred, non-limiting aspect, theradio-frequency identification chip is integrated within the body.

The use of a radio-frequency identification chip enables data relatingto the support itself to be maintained in a safe and mechanicallyinaccessible manner. In particular, the radio-frequency identificationchip can contain data that replace or duplicate data typically recordedby ink or engraving directly on the body of the support. The use of aradio-frequency identification chip further enables access to data takenfrom a large plurality of supports without any need to handle ormanipulate them. The reduction in the number of handling operations ormanipulations for reading data contributes to reducing the risk ofaccidental contaminations at least of the first portion of the absorbentmatrix.

In accordance with a twenty-ninth preferred, non-limiting aspect, saidmemory comprises at least one non-rewritable portion.

The first non-rewritable portion can be advantageously used to memorisea unique identification number of the support, making it possible tokeep track of it over time without the risk of duplications orfraudulent modifications.

In accordance with a thirtieth preferred, non-limiting aspect, thesupport, on the body thereof, comprises an identification profile foridentifying correct manipulation, designed to enable identification of aspecific orientation of the body and configured to be read by an opticalreader and/or a mechanical stop of a manipulator device.

In accordance with a thirty-first preferred, non-limiting aspect, theidentification profile for identifying correct manipulation is disposedat or substantially at the perimeter of the body.

The use of an identification profile for identifying correctmanipulation makes it possible to increase the precision of positioningand gripping by the manipulators of the support.

In accordance with a thirty-second preferred, non-limiting aspect, theabsorbent matrix comprises at least a third curved or bent part, forexample made by die-cutting, configured to compensate at least forexpansions or contractions, thermal or of another nature, of the plasticmaterial of the body, the third part being optionally fashionedsubstantially at a perimeter of the absorbent matrix.

The third part advantageously makes it possible to compensate fordimensional variations of the body of the support, thus preventingcurvature or tearing of the absorbent matrix.

In accordance with a thirty-third preferred, non-limiting aspect, saidthird part is fashioned in a junction zone between said absorbent matrixand the body.

In accordance with a further and thirty-fourth aspect, a productionprocess for producing a support for conserving a sample of biologicalmaterial is provided, the process comprising:

-   -   A step of defining a predefined shape for at least a first        portion of an absorbent matrix suitable and intended for the        conservation of a sample of biological material;    -   A step of positioning the at least a first portion of the        absorbent matrix in a mould, and of retaining the first portion        of the absorbent matrix in a predetermined position in the        mould;    -   A step of moulding or co-moulding or overmoulding plastic        material in empty spaces of the mould, after which a body for        retaining the at least a first portion of the absorbent matrix        is obtained, wherein the body retains said first portion of the        absorbent matrix at least in the second lateral part thereof;        and wherein    -   After the moulding or co-moulding or overmoulding step, said        first portion has a portion of a first face and of a second face        that are directly accessible.

In accordance with a thirty-fifth preferred, non-limiting aspect, afterthe moulding step, the body assumes a substantially planar shape,extending along a first and a second direction respectively definedalong a first reference axis (X) and a second reference axis (Y)orthogonal to the first reference axis.

In accordance with a thirty-sixth preferred, non-limiting aspect, thebody has a thickness, measured along a third reference axis (Z)orthogonal both to the first and the second reference axis, which isgreater than or equal to the thickness of the first portion of theabsorbent matrix.

In accordance with a thirty-seventh preferred, non-limiting aspect, thebody has a thickness equal to at least 0.8 mm or 1 mm, identifying atleast a first profile of discontinuity of thickness in a zone ofproximity to said first portion of the absorbent matrix.

In accordance with a thirty-eighth preferred, non-limiting aspect,alternative to the preceding thirtieth aspect, the body identifies afirst profile of discontinuity of thickness at the first face of thefirst portion of the absorbent matrix and a second profile ofdiscontinuity of thickness at the second face of the first portion ofthe absorbent matrix, substantially where the body at least partiallyoverlaps the first face and the second face.

In accordance with a thirty-ninth preferred, non-limiting aspect, thestep of making a first portion of an absorbent matrix having apredefined shape and suitable and intended for the conservation of asample of biological material, comprises a step of selecting a materialcomprising cellulose.

In accordance with a fortieth preferred, non-limiting aspect, thematerial comprising cellulose is of a preserving, in particularDNA-compatible, type.

In accordance with a forty-first preferred, non-limiting aspect, theabsorbent matrix has thickness comprised in the interval between 0.2 mmand 1 mm and preferably between 0.4 mm and 0.8 mm.

In accordance with a forty-second preferred, non-limiting aspect,depending on the preceding thirty-ninth aspect, said cellulose has athickness substantially equal to 0.6 mm.

In accordance with a forty-third preferred, non-limiting aspect, theprocess comprises

-   -   A step of defining a predefined shape for a second portion that        is separate from the first portion and suitable for, configured        and intended to constitute a cleaning zone for the head of a        device, in particular a punch, suitable for taking a sample of        biological material from the first portion;    -   A step of positioning the at least a second portion in the        mould, and retaining the second portion in a predetermined        position in the mould;    -   Wherein in the step of moulding or co-moulding plastic material        in empty spaces of the mould, a body for retaining the first        portion of an absorbent matrix and retaining the second portion        is obtained, wherein the body retains the first portion of the        absorbent matrix and the second portion at least in a second        lateral part thereof

In accordance with a forty-fourth preferred, non-limiting aspect, afterthe moulding or co-moulding step, the second portion has a portion of afirst face and of a second face that are directly accessible.

In accordance with a forty-fifth preferred, non-limiting aspect, asecond body portion is moulded, or co-moulded or overmoulded at leastpartially over a first body portion in order to produce two preferablysubstantially planar portions overlapping each other.

In accordance with a forty-sixth preferred, non-limiting aspect, thefirst body portion and the second body portion are seamlessly and/orindissolubly joined and/or form a monolithic and/or integral piece, inparticular as a result of a moulding or co-moulding or overmouldingprocess.

In accordance with a forty-seventh preferred, non-limiting aspect, thefirst portion of the absorbent matrix is a portion of thin, flexible,non-weight-bearing material.

In accordance with a forty-eighth preferred, non-limiting aspect, thesecond portion is a portion of thin, flexible, non-weight-bearingmaterial.

The use of a first and/or second portion of thin, flexible,non-weight-bearing material enables a great ease of perforation by apunching machine, in particular if the perforation takes place in adirection that is parallel or substantially parallel to the directionidentified by the third reference axis.

In accordance with a forty-ninth preferred, non-limiting aspect, theaforesaid process comprises a step of producing a compensator tocompensate for at least the expansion or contraction, for examplethermal, of the body and/or of the first portion of the absorbentmatrix, wherein said compensator is produced in the at least a firstportion of the absorbent matrix.

In accordance with a fiftieth preferred, non-limiting aspect, dependingon the aforesaid forty-fifth aspect, the step of producing saidcompensator comprises a step of producing at least a third curved orbent part, for example made by die-cutting, on the absorbent matrix.

In accordance with a fifty-first preferred, non-limiting aspect, thethird part comprises an undulation and/or bending of the absorbentmatrix suitable for defining a locally non-planar profile, andconfigured to stretch out and/or contract or bend when the body changesin its dimensions due to expansion or contraction, either thermal or ofanother nature, and/or when the first portion of the absorbent matrixundergoes expansions or contractions following the deposition of thesample of biological material.

In accordance with a fifty-second preferred, non-limiting aspect, theprocess comprises a step of positioning the absorbent matrix between tworetaining devices whose surfaces are of a matching shape, so as tocreate the third part, prior to the step of introducing the plasticmaterial into the mould.

In accordance with a further aspect, or fifty-third aspect, a device forthe analysis of biological samples is provided, the device beingcharacterised in that it comprises an apparatus for gripping a supportfor conserving one or more samples of biological material, and asample-taking device, in particular a punch, comprising at least a firstoperating configuration in which at least one portion thereof entersinto contact with said first portion of the absorbent matrix and takes apart of the latter.

In accordance with a fifty-fourth preferred, non-limiting aspect, thepunch comprises at least a first operating configuration in which atleast one portion thereof perforates said first portion.

In accordance with a fifty-fifth preferred, non-limiting aspect, thepunch comprises at least one operating configuration in which at leastone portion thereof perforates said first portion in a directionparallel or substantially parallel to the third reference axis (Z).

In accordance with a fifty-sixth non-limiting aspect, the sample-takingdevice, in particular a punch, further comprises a second operatingconfiguration in which at least one portion thereof enters into contactwith said second portion, carrying out an operation of cleaning and/ordisinfection.

In accordance with a fifty-seventh non-limiting aspect, thesample-taking to device is configured to position itself in the secondoperating configuration before being configured in the first operatingconfiguration.

In accordance with a fifty-eighth non-limiting aspect, the support cancomprise spacers, disposed on the upper or the lower face of the bodyand suitable for spacing further supports positioned side by side orstacked on top of one another.

In accordance with a fifty-ninth non-limiting aspect, the body is madein one piece and/or in a single piece.

In accordance with a sixtieth non-limiting aspect, the support cancomprise a plurality of first portions of an absorbent matrix, intendedfor the conservation of samples and fixed and maintained in apredetermined position, each within a respective, corresponding anddistinct first through opening of the body.

In accordance with a sixty-first non-limiting aspect, the support cancomprise a plurality of second portions of an absorbent matrix which aresuitable for, configured and intended to constitute cleaning zones forthe cutting head of a punch and fixed and maintained in a predeterminedposition, each within a respective, corresponding and distinct secondthrough opening of the body.

In accordance with a sixty-second non-limiting aspect, the support cancomprise a plurality of radio-frequency identification chip and/or aplurality of identification profiles.

In accordance with a sixty-third non-limiting aspect, the first throughopening and/or the second through opening can have a circular shape or asquare shape or any shape whatsoever that it is suited to the purpose.

In accordance with a sixty-fourth non-limiting aspect, the disclosurefurther relates to the use of a support, in accordance with what wasclaimed and/or specified in the preceding aspects, for the deposition ofbiological samples and/or for conserving biological samples and/or in amachine for the automatic treatment of supports for biological samplesand/or in an automated storage system for the treatment of supports forbiological samples and/or for taking biological samples by punching thefirst portion of an absorbent matrix and/or for cleaning a cutting headof a punch by punching the second portion of an absorbent matrix ormaterial suitable for cleaning.

For the purposes of the present disclosure, moulding, co-moulding andovermoulding exclude mechanical juxtapositions of parts made of aplastic material which are both already solidified, in particularremovable or in any case individualising juxtapositions, in particular afinished product, a joining portion where two pieces of plastic materialare not indissolubly and seamlessly joined.

DESCRIPTION OF THE FIGURES

A detailed description of one or more preferred embodiments will now beprovided by way of non-limiting example, in which:

FIG. 1 illustrates a perspective view of a first preferred andnon-limiting embodiment of the support 1 for conserving one or moresamples of biological material described herein;

FIG. 2 illustrates a plan view of the support in FIG. 1, observed alongthe direction of observation indicated by the arrow F;

FIG. 3 illustrates a side view of part of the support in FIG. 1, alongthe line indicated in FIG. 2;

FIG. 4 illustrates a sectional view of a specific embodiment of thesupport in FIG. 1, along the line Iv-Iv drawn in FIG. 2;

FIG. 5 illustrates a detailed sectional view of part of the support inFIG. 1;

FIG. 6 illustrates a plan view of a second preferred and non-limitingembodiment of the support 1 for conserving one or more samples ofbiological material described herein;

FIG. 7 illustrates a perspective view of part of the support in FIG. 1,in an intermediate step in the production of a variant embodiment;

FIGS. 8, 9, 10 illustrate sectional views of intermediate productionsteps for the support 1, according to a first production technique;

FIG. 11 illustrates a sectional view of a specific intermediateproduction step for the support 1, alternative to the step schematicallyillustrated in FIG. 10;

FIG. 12 and FIG. 13 illustrate sectional views of intermediateproduction steps for the support 1, in accordance with a specificproduction technique;

FIG. 14 and FIG. 15 illustrate sectional views of intermediateproduction steps for the support 1, in accordance with a specificproduction technique alternative to the one of FIGS. 12 and 13;

FIG. 16 illustrates a sectional view of the support as made after theprocess schematically illustrated in FIG. 14 and in FIG. 15;

FIG. 17 illustrates a sectional view of part of the support, in anintermediate construction configuration relative to the finalconstruction; and

FIG. 18 illustrates a side view of a part of a device for making thesupport of the concepts herein, in a particular configuration thereof.

DETAILED DESCRIPTION

With reference to the appended figures, the reference number 1 denotesin its entirety a support for conserving one or more samples ofbiological material.

The support 1 comprises at least an absorbent matrix 2, where absorbentmatrix 2 refers to a matrix support or any other support suitable andintended for the collection and in particular the conservation ofsamples of biological material.

As illustrated in the appended figures, and in particular in FIG. 1, thesupport 1 comprises a substantially rigid weight-bearing body 6, whichserves as a support for the absorbent matrix 2.

The support 1 further comprises at least a first portion 3 and a secondportion 4, preferably likewise made with an absorbent matrix 2. For thepurposes of the present disclosure, the aforesaid first portion 3 andthe second portion 4 are portions of heterogeneous material, which is inparticular distinct from the material the body 6 is made of.

The first portion 3 of the absorbent matrix 2 is suitable and intendedfor the absorption and conservation of a sample of biological materialand can be chemically treated in an appropriate manner to enhance theconservation of biological material, also for a long period of time. Theconservation of samples of biological material is fundamental inapplications in which there is a need to process the biological materialcollected, for example to perform subsequent analyses, even after a longperiod of time has elapsed since the moment when the sample to beanalysed was deposited on the absorbent matrix 2.

The second portion 4 is suitable for and configured to constitute acleaning zone for the surfaces of the sample-taking device that havecome into contact with the absorbent matrix 2, in particular in thefirst portion 3, upon the taking of a sample of biological material. Inparticular, said surfaces can belong to the head of a sample-takingdevice. The Applicant stresses that the “sample-taking device” describedin this paragraph is not the device with which the biological sample istaken in order to be deposited on the absorbent matrix 2, but rather adevice—for example an electromechanical device—conceived to take a partof the absorbent matrix 2, in particular of the first portion 3, inorder to enable laboratory tests to be performed on the biologicalsample supported thereupon.

In the context of the present description, head of a sample-takingdevice refers to one or more surfaces and/or portions of thesample-taking device suitable for removing a sample of biologicalmaterial from the absorbent matrix 2, in particular in the first portion3 of the absorbent matrix 2. For example, in the event that thesample-taking device is a punch, the surfaces suitable for coming intocontact with the biological material in the first portion 3 in order toremove a sample therefrom belong to the head of the punch. If thesample-taking device is a punch, it can be cleaned by punching, in a“blank” mode, the second portion 4 one or more times so that thematerial the second portion 4 is made of can remove the residues ofbiological material and/or the impurities on the surfaces of thesample-taking device suitable for taking portions of samples ofbiological material from the support 1.

In order to complete the cleaning efficiently and avoid contaminatingthe sample-taking device, no sample of biological material is depositedin the second portion 4 for the purpose of conserving it, so that thesecond portion 4 is maintained virgin.

The second portion 4 can be made of an absorbent material or any othermaterial capable of cleaning the head of the sample-taking device whenin contact with it. In particular, the second portion 4 can be made withthe same absorbent matrix 2.

The first portion 3 and the second portion 4 can be made of a samematerial or different materials and/or have characteristics differingamong them, acquired, for example, through one or more specificprocesses to which they have been subjected.

In particular, the first portion 3 can be configured, for example byadding specific substances suited to the purpose, to absorb and conservesamples of biological material, whereas the second portion 4 can beconfigured to absorb and/or remove residues of biological materialand/or impurities present on the surfaces of the sample-taking devicesuitable for taking portions of samples of biological material from thesupport 1.

As illustrated in FIG. 1 and in FIG. 2, the body 6 of the support 1completely encloses the first portion 3 and the second portion 4; thefirst portion 3 and the second portion 4 are each separated from theedge or perimeter of the body 6 by a part or portion of body 6. TheApplicant has observed that the manipulation of the body 6 can takeplace by gripping the perimeter of the body 6 itself; this gripping canalso be performed by the user manually, or by a robotised device,according to an automatic method. The portion of the body 6 thatseparates the perimeter of the support 1 at least from the first portion3, measured along the plane X-Y defined by the first and secondreference axes, measures at least 5 mm and, more preferably, at least 7mm or at least 10 mm. Thanks to this aspect, it is possible to avoidaccidental contaminations above all of the first portion 3 of theabsorbent matrix 2 when the body 6 is manipulated.

As illustrated in the appended figures, the body 6 of the support 1 forconserving a sample of biological material extends mainly along a firstand a second direction respectively identified by a first reference axisX and a second reference axis Y, preferably with a planar shape. Thefirst and second directions respectively identify a length and a widthof the body 6. The body 6 further extends along a third directionidentified by a third reference axis Z, orthogonal to the firstreference axis X and to the second reference axis Y; the third directionidentifies a thickness of the body 6. The body 6 thus identifies anupper face or first surface 8 and a lower face or second surface 9,opposite the first surface and, in particular, preferably parallelthereto.

The body 6 further identifies a lateral surface 7 which defines theperimeter of the body itself; said surface extends substantially alongplanes comprising at least the third reference axis Z; when the body 6has a rectangular shape, as in the case of the embodiment in theappended figures, the planes along which the lateral surface 7 extendsare in twos, comprising the first and the third reference axes X, Z, andthe second and third reference axes Y, Z.

The support 1 can further comprise a third portion 5. In anunillustrated variant, the third portion 5 can be interposed between thefirst portion 3 and the second portion 4, and preferably be a connectingportion between the first portion 3 and the second portion 4. In theembodiment illustrated in FIG. 6, the third portion 5 is not interposedbetween said portions. The third portion 5 is advantageously a portionof the absorbent matrix 2. The body 6 preferably comprises a thirdthrough opening in which the third portion 5 is housed, as illustratedin FIG. 6. In a preferred embodiment, the third portion 3 can besuitable for and intended to constitute a calibration portion of thedevice for taking the sample from the first portion, and, in greaterdetail, it can be intended to enable a verification of a colorimetricdifference existing between areas in which the sample of biologicalmaterial is deposited and areas without any biological sample. Thecolorimetric difference is emphasised, in particular, when the materialof the first portion changes colour after the sample of biologicalmaterial has been deposited, for example as a result of thecharacteristics of the sample and/or the presence of appropriatechemical substances on the first portion.

The first portion 3 and/or the second portion 4 and/or the third portion5 and/or the absorbent matrix 2 can preferably be made of acellulose-based material and/or made of a paper material, for exampleabsorbent paper or filter paper.

The absorbent matrix 2 can preferably be made of a cellulose-basedmaterial, for example made of a paper material, absorbent paper orfilter paper in particular. More in particular, the absorbent matrix canconsist of a cellulose-based material, such as, for example, paper,absorbent paper or filter paper in particular, which can be specificallytreated, in particular chemically, to enable the absorption andconservation of the collected samples of biological material. Thechemical treatment performed on the absorbent paper, if present, canpreferably be a preserving chemical treatment, in particular aDNA-compatible one; for the purposes of the present disclosure,“preserving” treatment, in particular a “DNA-compatible” one, should beunderstood as a treatment and/or material designed not to deterioratethe biological sample present on the absorbent paper, so as to be ableto permit a correct analysis thereof at a later time following themoment in which the biological sample is collected. More in particular,“preserving” treatment, in particular a “DNA-compatible” one refers to atreatment and/or a material that does not alter the DNA structure of thesample, but can comprise a bactericidal action configured to stop orlimit the proliferation of bacteria on the absorbent matrix 2. In fact,the absorbent matrix 2 can comprise or be totally or partiallyimpregnated with a compound or composition for protecting DNA,comprising, by way of non-limiting example, an acid joined to a base; inparticular, it can comprise uric acid joined to a weak base in order toconvert the uric acid into salts and provide an alkaline environment.

With the aim of enabling the biological samples to be conserved for along period, the absorbent matrix 2 is insoluble in liquids,specifically insoluble in biological liquids. Furthermore, preferably,but without limitation, the absorbent matrix 2 is made of a material, inparticular absorbent paper or filter paper, which is dimensionallystable when impregnated by a liquid, particularly when impregnated by abiological liquid. By virtue of this aspect, since the absorbent matrix2 is suspended, i.e. it possesses no support in the direction identifiedby the third reference axis Z for a substantial portion thereof, oneavoids an excessive warping of the same after the absorption of thebiological liquid in use held therein, thus preventing the risk thatsuch warping may cause contact between the absorbent matrix 2 and otherabsorbent matrices or other bodies 6 of adjacent supports 1.

The support 1 for conserving biological material comprises an outercontaining body 6, which is configured to house the first portion 3, thesecond portion 4 and/or the absorbent matrix 2 inside it, at leastpartially, and preferably completely. In other words, the body 6 canhave one or more seats intended to house the first portion 3, the secondportion 4 and, optionally, the third portion 5 and further portions ifpresent. For the purposes of the present disclosure, “inside” refers tothe fact that, at least when devoid of samples of biological material,the first portion 3 and in particular all of the portions 3, 4, 5, ifpresent in a larger number than the first portion, do not extend outsidethe profile defined by the body 6.

As briefly mentioned above, in accordance with an important aspect, atleast the first portion 3 made of an absorbent matrix 2 is positioned ina respective through opening 13 so as to be suspended for at least aportion thereof, preferably for a substantial portion thereof comprisingat least 70% of the surface of the absorbent matrix 2. In a particularembodiment, the support 1 can be provided with a first completelysuspended portion 3. In the suspended portion thereof, the aforesaidfirst portion 3 does not have the support of the body 6.

In particular, the first portion 3 has a lateral surface 7 extendingalong a plane that comprises the third reference axis Z, to which afirst and a second face or surface 28, 29, respectively larger andsmaller, are joined. The first and the second face or surface preferablylie in parallel planes, each of which comprises the first and the seconddirection identified by the first and second reference axes X, Y. Inparticular, at least one part or portion of the first and second face28, 29 is suspended.

For the purposes of the present disclosure, “suspended” refers to thefact that at least a first portion 3 has no support lying below or aboveit in a direction identified by the third reference axis Z. “Partiallysuspended” refers to the fact that the at least a first portion 3, forat least a sub-portion thereof, and in particular a portion or part ofthe first and/or second face, has no support lying below or above it ina direction identified by the third reference axis Z. When the firstportion is completely suspended, it is held solely by contact and/oradhesion in a second lateral part thereof extending over a plane or anumber of planes, also continuously when the first portion 3 assumes theform of a curve with no angular points, comprising the third referenceaxis Z.

The surfaces of the first portion 3 other than the second lateral part27 are preferably free, not interposed in a sandwich-like manner, andare thus directly accessible to contact. In the present text, the term“directly accessible to contact” refers to devoid of coverings of anykind, for example a film covering, and/or directly accessible forexample for depositing samples or taking portions by a punch. The firstportion 3 thus represents a first portion 3 of a single-layer absorbentmatrix 2.

In particular, under operating conditions of the containing body 6, thefirst portion 3 and the second portion 4 can be disposed inside the body6. “Operating conditions” of the body 6 refers to the condition in whichat least the first portion 3 and the second portion 4 are disposedinside the body 6. In particular, under operating conditions of the body6, the first portion 3 and the second portion 4 are suitably positionedinside the containing body 6 so that the first portion 3 is ready forthe deposit of a sample of biological material for the conservationthereof or for the taking of a sample of biological material and thesecond portion 4 is ready for cleaning the sample-taking device. Thefirst portion 3 and the second portion 4 can be distinct and/or appliedindividually to the support 1, in particular to the body 6.

As illustrated in FIG. 3 and in greater detail in FIGS. 4 and 5, apreferred and non-limiting embodiment of the support 1 can be providedwith a body 6 that has an upper portion 10 and a lower portion 11coupled to each other; in particular, along the direction identified bythe third reference axis Z, the upper portion 10 is juxtaposed to orsuperimposed on the lower portion 11. The upper portion 10 and the lowerportion 11 each have a respective thickness 17, 18 measured in adirection parallel to the direction identified by the third referenceaxis Z. More preferably, the upper portion 10 and the lower portion 11of the body 6 are made integrally and/or indissolubly coupled to eachother after a moulding or co-moulding or overmoulding process betterdescribed below.

The second portion 3 of an absorbent matrix 2 has its own thickness 16measured in a direction parallel to the direction identified by thethird reference axis Z. In particular, the thickness 16 measures lessthan the sum of the thicknesses of the upper portion 10 and lowerportion 11; relative to the first and second surfaces 8, 9, in thesecond portion 3 of the absorbent matrix 2, the body 6 thus identifiesat least a first profile of discontinuity of thickness, and inparticular, in accordance with the embodiments represented in theappended figures, a first and a second profile of discontinuity ofthickness 24, 25, each having respectively a first height 14 and asecond height 15, both measured along a direction parallel to thedirection identified by the aforesaid third reference axis Z.

In particular, it has been observed that the thickness 16 of the firstportion 3 of the absorbent matrix 2 is preferably about 0.6 mm and morein general comprised in the interval [0.4-0.8] mm. This thickness hasbeen observed to be the one with the best compromise between resistanceand the capacity to absorb liquids or fluids. For this reason, the firstportion of the absorbent matrix 2 is definable as a portion of a thin,flexible, non-weight-bearing material. For the purposes of the presentdisclosure, “non-weight-bearing” refers to a material that, inparticular in the specific configuration of thickness definedpreviously, does not have characteristics such as to and is notconfigured to act as a support for itself or for further materialsand/or layers, as it is substantially completely flexible or limp.

When the second portion 4 and/or the subsequent portions are present inthe specific embodiment actually produced, and in particular when saidat least a second portion 4 is also made of an absorbent matrix 2 as inthe first embodiment, the thickness measurements previously mentionedfor the first portion 3 are also applicable to the aforesaid at least asecond portion 4.

The Applicant has further found that the first and second profiles ofdiscontinuity of thickness 24, 25 are useful for enabling a number ofsupports 1 to be stacked without the respective first portions 3 of theabsorbent matrix 2 touching one another. Although the presence of onlyone between the first and a second profile of discontinuity of thicknessmay be sufficient to enable a number of supports 1 to be stacked withoutthe respective first portions 3 of the absorbent matrix 2 touching oneanother, the presence of a first and of a second profile ofdiscontinuity of thickness ensures a larger margin, with a reduction inthe risk of reciprocal contamination between two or more first portions3 of the absorbent matrix 2 without contact, also when the absorbentmatrix 2 bends due to the weight of the liquid or fluid absorbed. Thissolution also makes it possible to reduce the risk of contamination ofthe first portion 3 of the absorbent matrix 2 by the walls of the rackon which the supports 1 can be stacked.

In order to enable a support of sufficient sturdiness to be obtained,the overall thickness of the support 6, and hence the sum of thethicknesses 17, 18 of the upper portion 10 and the lower portion 11, ispreferably equal to at least 1 mm, and preferably comprised in theinterval 1.2 mm-1.4 mm, more preferably substantially equal to 1.3 mm.In FIG. 4 and in FIG. 5 an embodiment is illustrated in which thethickness of the upper portion 10 is equal to the thickness of the lowerportion 11; for example, if the overall thickness of the support 6 isequal to 1.2 mm, each portion will have a thickness equal to 0.6 mm.However, it is possible to have an upper portion 10 with a thicknessdiffering from the thickness of the lower portion 11.

Preferably, but without limitation, the dimensional ratio issubstantially comprised in the interval between 1:1.25 (for example,thickness of the body 6 equal to 1 mm, thickness of the at least a firstportion 3 equal to 0.8 mm) and 1:3.5 (for example, thickness of the body6 equal to 1.4 mm, thickness of the at least a first portion 3 equal to0.4 mm) or 1:5 (for example, thickness of the body 6 equal to 1.5 mm,thickness of the at least a first portion 3 equal to 0.3 mm).

The body 6 of the support 1 is preferably, but without limitation, madeof a plastic material, and even more preferably made of a materialsusceptible of being moulded or co-moulded or overmoulded. After themoulding, co-moulding or overmoulding process, the body 6 of the support1 assumes a structure that is integral or in a single body, wherein theplastic material with which the body is made is indissolubly bonded,extending continuously and/or uninterruptedly in particular along adirection substantially parallel to the Z axis, that is, through thethickness, in particular the entire thickness, of the body 6. In apreferred embodiment, the body 6 is made of a single piece. The plasticmaterial is preferably crystal polystyrene, for example 100%.Non-limiting examples of plastic materials suitable for being moulded orco-moulded are polyolefin plastic materials, including polypropylene, orvinyl plastic materials, including polyvinylchloride, or else styrene orpolyester-based plastic materials, including polycarbonate orpolyethylene. Preferably, but without limitation, use is made of plasticmaterials with a low property of chemical interaction with the absorbentmatrix 2, in particular when made of cellulose. This advantageouslymakes it possible to leave, above all, the first portion 3 free ofcontaminating agents as much as possible, even after particularly longstorage.

The Applicant notes that, in particular for the first portion 3—suitablefor accommodating the biological sample when in use—and, subordinately,for the at least a second portion 4—it is important that in theproduction process of the support 1 there be no interactions between theplastic material of the body 6 and the cellulose which is part at leastof the absorbent matrix 2; for this reason, among the plastic materialsdescribed previously, it can be advisable to select plastic materialswhich, combined with a low chemical interaction with the absorbentmatrix 2, also have a low moulding temperature, and in particular amoulding temperature that is less than or equal to a temperature atwhich the absorbent matrix 2 undergoes deterioration or damage. A lowmoulding temperature of the plastic material contributes to reducing therisk of widespread alteration in the chemical characteristics of theabsorbent matrix 2, since, particularly in the junction zones, theabsorbent matrix 2 will heat up less. It has been observed, inparticular, that in the event that polyvinylchloride is the selectedplastic material, correct moulding operations can be achieved with atemperature starting from 150° C. and up to 200° C.-210° C.

FIG. 6 illustrates an alternative embodiment of the support 1. In thisalternative embodiment, in addition to the elements describedpreviously, the body of the support 1 can have a unique identificationcode 30 integrated therewith, preferably, but without limitation,represented on the upper surface or first surface 8 of the body 6. Moreparticularly, the unique identification code 30 can be represented byapplying ink, preferably indelible or, alternatively, engraved, forexample, by a laser. Thanks to this feature, each support 1 can benumbered or distinguished clearly from the others; this can benefit boththe manufacturer of the support 1, because it can keep track ofprecisely which and how many supports 1 have been distributed among itsvarious customers, and users. The latter will advantageously have thepossibility of precisely selecting which, among the various supports attheir disposal, is the one that is of interest. For example, the uniqueidentification code 30 can be made in the form of a barcode or QR codeor any further known code with graphic representation.

The support 1, as represented in FIG. 6, can likewise be provided with aradio-frequency identification chip 31. The radio-frequencyidentification chip 31 is preferably introduced inside the body 6, andeven more preferably it is embedded therewithin, so that no part of itprojects outside the profile of the support. The radio-frequencyidentification chip 31 can be of the semi-active or passive type, thelatter alternative being the preferred one. The use of a radio-frequencyidentification chip 31 of a passive type enables the presence of abattery to be completely avoided and thus enables the chip to be energyindependent from permanent power sources.

A memory of a non-volatile type may be conveniently accommodated withinthe radio-frequency identification chip 31, more preferably, but withoutlimitation, one having at least one inalterable, i.e. non-rewritableportion; the unique identification code represented or representable onthe body 6 is preferably memorised within that portion. The memorisationof the unique identification code inside the radio-frequencyidentification chip advantageously makes it possible to verify which andhow many supports 1 are in the possession of a specific user or aspecific customer by remote reading, in particular without direct accessto the upper surface or first surface 8 of the body 6. Thisadvantageously allows the possibility of reading the support 1 even ifit is stacked or closed in a storeroom. Further portions of the memorycan be writable by the user to memorise data of interest therein,preferably data relating to the biological sample contained in theabsorbent matrix 2.

The radio-frequency identification chip 31 is preferably an RFID chipthat can operate, for example, over a predetermined frequency—by way ofnon-limiting example, 134 kHz or 13.56 MHz. Conveniently, with the useof the frequency 13.56 MHz, particularly if the access protocol complieswith standard ISO 14443 or 15693, it is possible to read theradio-frequency identification chip remotely over a maximum range of 10cm (ISO 14443) or 1 m (ISO 15693). The limitation of the maximum rangefor reading the radio-frequency identification chip advantageously makesit possible to prevent ill-intentioned persons from being able toremotely read the data contained in supports 1 that do not belong tothem. In order to increase security in the reading of the electronicdata contained in the memory of the radio-frequency identification chip31, it is likewise possible for the electronic data to be encrypted.

Furthermore, the support 1 can comprise an identification profile foridentifying correct manipulation. In a preferred and non-limitingembodiment, the identification profile 32 for identifying correctmanipulation, illustrated in FIG. 6, is preferably, but withoutlimitation, disposed at or substantially at the perimeter of the body 6.The identification profile 32 for identifying correct manipulation canadvantageously comprise an asymmetric lateral perimeter; in particular,an embodiment of the support 1 that has a bevelled corner at the lateralsurface 7 is represented in FIG. 6. The identification profile 32 foridentifying correct manipulation is conveniently usable as a mechanicaland/or optical stop profile. More in particular, the Applicant hasobserved that the identification profile for identifying correctmanipulation can be “read” by a mechanical stop present on an automaticdevice for manipulating the support 1 and/or be automatically recognisedby an optical reader for reading the same support 1.

Finally, the support 1 can comprise spacers 34 disposed on the uppersurface or first surface 8, suitable for enabling a further separationof the same surface, and thus at least also of the first portion 3, fromfurther surfaces and/or portions of supports 1 placed side by side orstacked in the direction identified by the third reference axis Z. In apreferred and non-limiting embodiment, the spacers 34 assume a domeshape. Preferably, but without limitation, the spacers 34 are disposedalternatively either on the upper surface 8 or lower surface 9 of thebody 6; by positioning the spacers on only one face of the body 6, oneprevents the possibility of the spacers 34, in particular when a numberof supports 1 are stacked along the direction identified by the thirdreference axis Z, coming into reciprocal contact, thus leading to amisalignment of the supports 1. Alternatively, the spacers 34 can bepositioned on both the upper surface 8 and lower surface 9 of the body6, but in such a configuration it is advisable that the spacers 34present on the upper face 8 not be aligned—in the direction identifiedby the third reference axis Z—with the spacers 34 present on the lowersurface 9.

The production of the support 1 to which the present disclosure relatesfollows the process described here below.

As illustrated in FIG. 7 and in FIG. 8, a first step of the productionprocess for producing the support 1 can comprise making a base or lowerportion 11 made of a plastic material, and fashioning at least a firstthrough opening 13 therein in a predetermined zone in which the firstportion 3 of the absorbent matrix 2 will subsequently be positioned.Further steps of the production process for producing the support 1 cancomprise making a number of seats 13 in predetermined zones in which thesecond portion 4 and/or the third portion 5 will be positioned, ifpresent in the support 1 as conceived for the specific use. These stepsare thus optional and depend on the number of portions included in thesupport 1. In particular, FIG. 8 illustrates this step of the processfor an embodiment of the support 1 configured to include a first portion3 and a second portion 4; the number of seats 13 is therefore equal totwo. In the case of the embodiment of FIG. 6, there are three seats 13.

The seats 13 for the first portion 3, the second portion 4 and/or thethird portion 5 are made in such a way as to be separate from oneanother, thus allowing a part of the body 6 to act as a guard interval12. Preferably, but without limitation, the guard interval is not lessthan 2 mm and it is preferably not less than 4 mm. In this manner, thesecond portion 4 and/or third portion 5 will also be separate from eachother so as to avoid reciprocal contaminations, also in the event ofpartial, incorrect and/or imprecise positioning of the portionsthemselves.

The absorbent matrix 2 is subsequently positioned over the throughopening 13 in the predetermined zone for the placement of the firstportion 3 of the absorbent matrix 2, and retained by a retaining device.Alternatively, the absorbent matrix 2 can be retained by gluing aperipheral area thereof 26 overlapping the upper face 21 of the lowerportion 11. Advantageously, in order to make this overlap possible, theabsorbent matrix 2 is first cut or in any case produced in such a way asto exceed the dimensions of the respective through opening 13. FIG. 9illustrates this step for an embodiment of the support 1 that comprisesa first portion 3 and a second portion 4. In this case, the secondportion 4, too, is retained by a retaining device or is alternativelyglued onto a peripheral area thereof overlapping the upper face 21 ofthe lower portion 11.

The production process for producing the support 1 subsequentlycomprises a step of positioning the upper portion 10 of the body 6 onthe assembly formed by at least the first portion 3 of absorbent matrix2 and the lower portion of the body 6. In greater detail, thepositioning step comprises a moulding or co-moulding or overmoulding aplastic material on the support formed by the lower portion 11 of thebody 6. For the purposes of the present disclosure, “moulding” refers toa technique which can comprise injection or compression moulding orrotational moulding, or another technique suited to the purpose, andpreferably consists in injection moulding, in order to join the upperportion 10 and the lower portion 11 indissolubly through at least amechanical joining leading to the definition of a structure that,especially once cooled, is definable as having been made monolithicallyand/or is definable as “monolithic”, and extends seamlessly along theaxis Z.

Through this step, which is schematically represented in FIG. 10, theupper portion 10 of the body 6 is deposited or moulded at least aroundthe area identified by the first portion 3 of the absorbent matrix, inparticular by entering into contact at least with the second lateralpart 27 thereof. If the upper portion 10 of the body 6 is deposited ormoulded in such a way as to enter into contact with the second lateralpart 27 of the first portion 3, the second lateral part 27 becomes anarea of contact and retention in position in the through opening of thefirst portion 3 itself. Fixing of the first portion 3 in the body 6, inparticular in the through hole, is thus optimised; the risk that thefirst portion 3 of the absorbent matrix moves relative to the body, oris even detached from the latter, is considerably reduced compared tocoupling solutions in which the absorbent matrix is interposed betweentwo panels that are premade and/or joined to each other by mechanicalinteraction, for example by inserting the projecting portions thereofagainst each other.

FIG. 11 illustrates a variant of the step of positioning the upperportion 10 of the body 6 by moulding or co-moulding plastic material onthe support formed by the lower portion 11 of the body 6. In thisvariant, the upper portion 10 of the body 6 at least partially overlapsthe first portion 3 of the absorbent matrix 2, thus defining an area ofcontact that comprises both the second lateral part 27 of the firstportion 3, and part of the upper face thereof This configurationadvantageously makes it possible to produce a body 6 capable ofretaining at least the first portion 3 of the absorbent matrix 2 alongthe direction identified by the third reference axis Z, both ways. Thismakes it possible, during use, to reduce the risk of the first portion 3being detached from the body 6, in particular after punching.

A further alternative of the production process for producing thesupport 1 is described in FIGS. 12 and 13. In this further alternative,a first step of the process comprises cutting a portion of an absorbentmatrix 2 according to a predetermined shape, after which the portion ofthe absorbent matrix 2 is positioned in a retaining device 100 inside amould.

Plastic material is subsequently moulded or co-moulded or overmoulded atleast around the portion of absorbent material 2 retained by theretaining device 100. In particular, the retaining device 100 can retainthe portion of the absorbent matrix 2 in such a way as to leave only thesecond lateral part exposed. In accordance with this aspect, the plasticmaterial, when moulded or co-moulded or overmoulded, enters into contactat least with the second lateral part 27 of the portion of the absorbentmatrix 2. The dimensions of the retaining device 100 along the planeidentified by the aforesaid first and second reference axes X, Y aretherefore equal to the dimensions assumed, respectively, by the firstportion 3 and second portion 4. In this case, illustrated in the variantof FIGS. 12 and 13, the first portion 3 of the absorbent matrix 2 isretained exclusively by the lateral surface thereof, which issubstantially oriented along the third reference axis Z.

In particular, FIGS. 12 and 13 illustrate an embodiment in which thesupport 1 comprises a first portion 3 and a second portion 4. The secondportion 4 is retained by a second retaining device 100, conveniently inthe same configuration as the retaining device 100 used to retain theportion of the absorbent matrix 2.

The plastic material is subsequently moulded or co-moulded orovermoulded within the mould 200, filling the space previously occupiedby the cavities 201, 202, 203 and thus forming the body 6.

A variant of the production process for producing the support 1described above is represented in FIGS. 14 and 15. In this furtheralternative, a first step of the process comprises cutting a portion ofan absorbent matrix 2 according to a predetermined shape, after whichthe portion of the absorbent matrix 2 is positioned in a retainingdevice 100 inside a mould.

Plastic material is subsequently moulded or co-moulded or overmoulded atleast around the first portion 3 of the absorbent matrix 2 retained bythe retaining device 100. In particular, the retaining device 100 canretain the portion of the absorbent matrix 2 in such a way as to leaveonly the second lateral part exposed. In accordance with this aspect,the plastic material, when moulded or co-moulded or overmoulded, entersinto contact with the second lateral part 27 of the portion of theabsorbent matrix 2 and with part of the lower and upper surfacesthereof. In particular, FIGS. 14 and 15 illustrate an embodiment inwhich the support 1 comprises a first portion 3 and a second portion 4.The second portion 4 is retained by a second retaining device 100,conveniently in the same configuration as the retaining device 100 usedto retain the portion of the absorbent matrix 2. The dimensions of theretaining device 100 along the plane identified by the aforesaid firstand second reference axes X, Y are thus smaller than the dimensionsassumed, respectively, by the first portion 3 and the second portion 4.This configuration advantageously makes it possible to form thepreviously mentioned first and second profiles of discontinuity ofthickness, thanks to which the first and second portions 4 are retainednot only by their lateral surface 7, but also in a direction parallel tothe direction identified by the third reference axis Z.

The plastic material is subsequently moulded or co-moulded orovermoulded within the mould 200, filling the space previously occupiedby the cavities 201, 202, 203 and thus forming the body 6 in a singlepiece, thereby obtaining a support 1 for biological materials as perFIG. 16, which has the same features as the support 1 represented inFIG. 5, with the difference that the upper and lower portions of thebody 6 are in this case replaced by a single portion of body 6, whosethickness is substantially given by the sum of the thicknesses of theportions mentioned previously.

For all variants of the production process described thus far, when themanufacturer selects the particular plastic material, a step of theproduction process can comprise identifying the temperature or intervalof temperatures at which the plastic material can be correctly moulded,and, within the aforesaid interval, proceeding to select the minimum orsubstantially the minimum among the temperatures in the aforesaidinterval in order then to proceed to heat the plastic material at theaforesaid temperature. Thanks to this aspect, it is possible to minimisethe alteration of the cellulose that is part of the absorbent matrix 2.

In the production process for producing the support 1, if it is desiredto obtain an embodiment provided with a unique identification code 30, astep—preferably electronic—of assigning a unique identification numberto a specific support 1 is performed, followed by a step of transformingthe unique identification number into a visual code that is subsequentlytransferred onto the body 6 of the paper. The Applicant has observedthat, in particular when the transfer takes place by laser, it isadvisable to maintain a predetermined distance, at least equal to 2-3mm, between the unique identification code 30 and at least the firstportion 3 of the absorbent matrix 2, in order to avoid contaminations oralterations due to use of the aforesaid laser.

The Applicant has further observed that plastic materials, andparticularly the ones mentioned above for the production of the body 6,are subject to dimensional change according to temperature. Inparticular, the Applicant has observed that the coefficient of linearthermal expansion of plastics typically ranges between 0.014 and 0.2mm/m/° C. The Applicant has conceived a production process that takesinto account this coefficient of linear thermal expansion of plasticmaterials with the aim of mitigating and if possible reducing theadverse effects on the absorbent matrix 2. This aspect has been noted inparticular because the step of moulding or co-moulding or overmouldingare steps distinguished by the fact of having a considerable change intemperature between when the plastic is moulded or co-moulded orovermoulded and when the plastic, cooled, renders the support 1 readyfor use. The temperature change can substantially be around 80° C. ormore. With a temperature change towards cooling, the effect that can beobtained on the body 6 is a reduction in the overall dimensions alongthe first and/or second and/or third reference axis X, Y, Z, andsimultaneously an increase in the size of the through opening 13, for atleast the first portion 3 of the absorbent matrix 2 and—if present—forthe further portions 4, 5.

In particular the Applicant has observed that, especially where plasticswith a high thermal expansion coefficient are used, the contraction ofthe plastic can provoke breakage of the absorbent matrix 2 or ungluingfrom the zones of contact thereof with the body 6. The reduced thickness16 of the absorbent matrix 2 makes breakage thereof by tearingparticularly easy, in particular due to traction along the firstreference axis X and/or along the second reference axis Y; breakage bytearing is particularly easy in particular since the matrix 2 has asubstantially stable size, i.e. it has little elasticity. For thisreason, the Applicant has advantageously conceived a compensator forcompensating dimensional alterations, in particular extensions orcontractions, of the body 6, which is provided in the position of theabsorbent matrix 2.

The Applicant has likewise observed that the first portion 3 of theabsorbent matrix 2 could be subject to phenomena of alteration due toextension or contraction, particularly along the first reference axis Xand/or second reference axis Y, especially when the sample of biologicalmaterial is deposited.

A first alternative for resolving the above-mentioned problem, beforethe plastic material is moulded or co-moulded or overmoulded at leastaround the first portion of the absorbent matrix 2 retained by theretaining device 100, consists in leaving the portion of the absorbentmatrix 2 limp, so that after the cooling of the plastic material, thethermal contraction thereof causes a pulling of the absorbent matrix 2such as to bring it into an almost planar configuration where the firstand second faces 28, 29, respectively upper and lower, lie in parallelplanes, each of which comprises the first and second directionsidentified by the first and second reference axes X, Y. The firstalternative is applicable both in the event that the body 6 is made byfirst forming the first lower portion 11 and subsequently the secondupper portion 10, the portions overlapping each other in the directionidentified by the third reference axis Z, and in the event that the body6 is made in the form of a unitary element.

A second alternative for resolving the above-described problem consistsin defining, before the plastic material is moulded or co-moulded orovermoulded at least around the first portion of absorbent matrix 2retained by the retaining device 100, a third part 22 for the absorbentmatrix 2 suitable for compensating for thermal expansions orcontractions of the plastic material of the body 6, both in extensionand in contraction, after which the through opening 13 where the firstportion 3 of the absorbent matrix 2, changes size. This secondalternative is schematically represented in FIGS. 17 and 18. The secondalternative is applicable both in the event that the body 6 is made byfirst forming the first lower portion 11 and subsequently the secondupper portion 10, which overlap each other in the direction identifiedby the third reference axis Z, and in the event that the body 6 is madein the form of a unitary element.

As may be observed in FIG. 17, the third part 22 comprises anundulation, in particular along the plane X,Y of the surface of theabsorbent matrix 2. The undulation, in a preferred, but non-limitingembodiment, is formed in proximity to the perimeter of the absorbentmatrix 2, and more in particular extends over the whole perimeter of theabsorbent matrix 2. The portion of the absorbent matrix 2 notcharacterised by the presence of the third part 22 is substantiallyplanar, and in particular oriented along a plane parallel to the planeidentified by the first reference axis X and the second reference axisY.

The third part 22, during the phase of contraction in the size of thebody 6 caused by cooling of the plastic material after moulding,stretches out; the undulation is progressively reduced in width untilthe entire free surface of the absorbent matrix 2 is brought into acondition of parallelism or substantial parallelism with the plane X,Y.The third part 22 thus has at least a first configuration of use ofgreater extension, suitable for compensating for an expansion of thedimensions of the through opening 13 for the first portion 3 ofabsorbent matrix 2—due to a thermal contraction of the body 6—and atleast a second configuration of use of smaller extension or greaterbending, suitable for compensating for a contraction of the dimensionsof the through opening 13 for the first portion 3 of absorbent matrix2—due to an expansion or contraction of the body 6, be it thermal or ofanother nature.

In order to produce the third part 22, as illustrated in FIG. 18, usecan be made of a retaining device 100 whose surface in contact with theabsorbent matrix 2 has a shaped profile 101, and a retaining device 100,opposing the previous one, whose surface in contact with the absorbentmatrix 2 has a recess 102 of a shape matching that of the profile 101.In other words, the step of retaining the absorbent matrix 2 within themould can comprise a step of positioning the absorbent matrix 2 betweentwo retaining devices 100 whose surface has a matching shape, so as tocreate the third part 22, for example prior to the step of introducingplastic material into the mould.

The production process for producing the support 1 subsequentlycomprises a step of introducing the plastic material into the mould soas to create a locking of the at least a first portion 3 of theabsorbent matrix 2 onto the body 6; after this step, a step of coolingthe plastic material within the mould 200 causes a contraction of thedimensions of the body 6, which comprises a variation in the dimensionsof the through opening 13 affecting the at least a first portion 3 ofthe absorbent matrix 2, with a consequent extension, in particular atleast a partial one, of the third part 22 of the absorbent matrix.

The applicant has observed that the presence of a third part 22, whosesurface can be extended or contracted, for example due to a variation inthe dimensions of the body 6, advantageously avoids curvatures of theabsorbent matrix 2 which could exceed the thickness of the first andsecond profiles of discontinuity of thickness 24, 25, so that theabsorbent matrix 2, if the third part 22 were not present, could enterinto contact with potentially contaminating materials or bodies. Forthis reason, the third part 22 represents the optimal solution where itis desired to reduce the risk of accidental contacts of the absorbentmatrix 2 with potentially contaminating materials or bodies, especiallyin the event that the support 1 is subjected, during the step of takinga biological sample or processing the same, to particular cooling orheating operations at temperatures other than typical ambienttemperatures.

The present disclosure further relates to a device for taking and/oranalysing samples of biological material. The device comprises at leastone apparatus configured to firmly grip the support 1, in any of theembodiments described previously, in order to place it in a position fortaking the sample of biological material. The device for taking and/oranalysing samples of biological material is configured in particular todispose a punch thereof at least over the first portion 3 of theabsorbent matrix 2 where the sample of biological material has beenpreviously deposited. Specifically, in a first operating configurationthe punch enters into contact with, and in particular perforates, theabsorbent matrix 2 in a direction preferably substantially parallel tothe third reference axis Z. Said perforation is followed by a removal ofa part of the absorbent matrix 2 of the first portion 3, which issubsequently examined by a technique that is not the subject matter ofthe present application and is therefore not described.

In a particular embodiment, the device for taking and/or analysingsamples of biological material can be further equipped with a processingunit electrically connected with a radio frequency stage provided withan antenna specifically conceived to read the radio-frequencyidentification chip 31. The data processing unit can be a generalpurpose processor specifically configured through a software or firmwareprogram to carry out one or more parts of the process describedpreviously, or an ASIC or dedicated processor, specifically programmedto carry out at least part of the operations of the method or process asper the present disclosure.

Prior to the step of taking a sample of biological material, the devicefor taking and/or analysing samples of biological material isconfigured, preferably, to set itself in a second operatingconfiguration in which the punch is positioned over the second portion4, and wherein at least part of the punch is cleaned before the sampleof biological material is taken. In particular, the punch is cleaned byperforation of the second portion 4, preferably along a directionsubstantially parallel to the direction identified by the thirdreference axis. After being positioned in the second operatingconfiguration, the punch goes into the first operating configuration inorder to extract the sample of biological material that will besubjected to analysis from the support 1. The concepts herein make itpossible to avoid contamination of the portion of the absorbent matrixsuitable for conserving a sample of biological material. The conceptsherein enable a simpler and more rapid cleaning of the sample-takingdevice. The concepts herein further make it possible to provide asupport for biological samples having an optimal rigidity so as to avoidundesirable bending of the support and enable an efficient automaticmanipulation of the support itself, thus preventing undesirablecontaminations of the biological sample. The concepts herein aremoreover convenient to use, easily implementable and simple andeconomical to produce.

It is clear, finally, that the support of the concepts herein canundergo modifications or additions that are obvious to the personskilled in the art without going beyond the scope of protection providedby the appended claims. The subject matter of the present disclosure isnot limited to the embodiments illustrated in the drawings. Therefore,it should be understood that where some features mentioned in the claimsare followed by reference numbers or symbols, such numbers or symbolsare included solely for the purpose of increasing the is intelligibilityof the claims and do not limit the scope of protection thereof

1. A support for conserving a sample of biological material, the supportcomprising: a substantially rigid body made of moulded or co-moulded orovermoulded plastic material, comprising a first through opening; atleast a first portion of an absorbent matrix, preferably made of amaterial comprising cellulose, suitable and intended for conserving asample of biological material; the first portion of the absorbent matrixbeing fixed and maintained in a predetermined position within the firstthrough opening; wherein the first portion of the absorbent matrix has afirst part without support from the body and which is suspended insidethe first through opening, the first part of the first portion of theabsorbent matrix being directly accessible to contact.
 2. The supportaccording to claim 1, wherein the first portion of the absorbent matrixis provided with a second lateral part constrained to the body and/or incontact with and/or adhering to the body and/or inserted in the body andsurrounded and enclosed by the body; the first portion of the absorbentmatrix being maintained in a predetermined position within the firstthrough opening at least by fastening, contact and/or adhesion betweenthe second lateral part of the first portion of the absorbent matrix andthe body.
 3. The support according to claim 1, further comprising asecond portion of the absorbent matrix, preferably made of materialcomprising cellulose, or a second portion of material suitable forcleaning a cutting head of a punch which is suitable for, configured andintended to constitute a cleaning zone for the cutting head of a punchsuitable for taking a sample of biological material from the firstportion; the body further having a second through opening distinct fromthe first through opening and the second portion being fixed andmaintained in a predetermined position inside the second throughopening, wherein the second portion of the absorbent matrix has at leasta first part without support from the body and which is suspended insidethe second through opening, the first part of the second portion beingdirectly accessible to contact, and wherein the second portion of theabsorbent matrix further has a second lateral part constrained to thebody and/or in contact with and/or adhering to the body and/or insertedin the body and surrounded and enclosed by the body.
 4. The supportaccording to claim 1, wherein the body is made by moulding orco-moulding or overmoulding plastic material on the second lateral partof the first portion of the absorbent matrix and/or on the secondlateral part of the second portion of the absorbent matrix.
 5. Thesupport according to claim 1, wherein at least the first portion of theabsorbent matrix has a thickness that is smaller than a correspondingthickness of the body at the first through opening, wherein thethickness of the body is equal to or greater than 1.0 mm, morepreferably comprised in the interval of 1.2 mm-1.4 mm, and/or equal toor less than 3.0 mm, more preferably 2.0 mm, and/or the thickness of thefirst portion of the absorbent matrix is equal to or greater than 0.2 mmor 0.4 mm, more preferably 0.5 mm or 0.6 mm and/or equal to or less than1 mm, more preferably 0.8 mm.
 6. The support according to claim 3,wherein: the body has at least a first profile of discontinuity ofthickness in a zone of proximity to the first portion of the absorbentmatrix; or wherein the body has at least a first profile ofdiscontinuity of thickness and a second profile of discontinuity ofthickness (25) in a zone of proximity to the first portion of theabsorbent matrix and/or wherein a part of the body overlaps part of afirst face or surface and of a second face or surface of the firstportion of the absorbent matrix, and wherein the portions of the bodyoverlapping the first portion of the absorbent matrix create a stoppreventing the axial mobility of the first portion of the absorbentmatrix relative to the body.
 7. The support according to claim 1,wherein the body is a substantially planar body extending mainly along afirst and a second direction respectively identified by a firstreference axis (X) and a second reference axis (Y) identifying an upperface and a lower face opposite the upper face, wherein the first throughopening and the second through opening extend substantially along adirection identified by a third reference axis (Z) orthogonal to thefirst reference axis (X) and wherein the first portion of the absorbentmatrix has a first face and a second face substantially parallel to theupper face and/or to the lower face and/or wherein the first face andthe second face of the first part of the first portion of the absorbentmatrix are directly accessible to contact and/or wherein the body has aflat conformation and/or a card shape.
 8. The support according to claim1, comprising at least one a radio-frequency identification chipintegrated within the body and comprising one a memory suitable forcontaining electronic data, wherein the memory preferably optionallycomprises one a non-rewritable portion, and/or comprising one anidentification profile for identifying correct manipulation, designed toenable identification of a specific orientation of the body andconfigured to be read by an optical reader and/or a mechanical stop of amanipulator device; and/or wherein the identification profile foridentifying correct manipulation is disposed at or substantially at theperimeter of the body.
 9. The support according to claim 1, wherein atleast the first portion of the absorbent matrix is provided with atleast a third part curved or bent, for example made by die-cutting,configured to compensate at least for expansions or contractions,thermal or of another nature, of the plastic material of the body and/orcontractions or expansions of the first portion of the absorbentmaterial, the third part being interposed between the first part and thebody or the second lateral part and/or being disposed substantially at aperimeter of the first part of the absorbent matrix in proximity to thebody and/or wherein also the second portion of the absorbent matrix isprovided with an equivalent curved or bent third part.
 10. A productionprocess for producing a support for conserving a sample of biologicalmaterial, the process comprising: A step of making a first portion ofabsorbent matrix, preferably from a material comprising cellulosesuitable and intended for the storage of a sample of biologicalmaterial; A step of positioning the first portion of the absorbentmatrix in a mould, and of retaining the first portion of the absorbentmatrix in a predetermined position in the mould; A step of moulding orco-moulding or overmoulding plastic material in empty spaces of themould, after which a body is made to retain the first portion of theabsorbent matrix, wherein the body is provided with at least a firstthrough opening and is fixed to the first portion of the absorbentmatrix at least in a second lateral part of the first portion andwherein the first portion has a first part without support from the bodyand which is suspended inside the first through opening, the first partof the first portion of the absorbent matrix being directly accessibleto contact.
 11. The production process according to claim 10, whereinafter the moulding step, the body assumes a substantially planar shape,extending along a first and a second direction respectively definedalong a first reference axis (X) and a second reference axis (Y)orthogonal to the first reference axis, and/or wherein the body has athickness, measured at the first through opening and along a thirdreference axis (Z) orthogonal both to the first and the second referenceaxis, which is greater than the thickness of the first portion of theabsorbent matrix and preferably at least equal to 1 mm and/or whereinthe body has at least a first profile of discontinuity of thickness in azone of proximity to the first portion of the absorbent matrix, oroptionally a first profile of discontinuity of thickness at the firstface of the first portion of the absorbent matrix, and a second profileof discontinuity of thickness at the second face of the first portion ofthe absorbent matrix, substantially where the body at least partlyoverlaps the first face and the second face.